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Notification report


Full notification file


General information

Notification Number
B/ES/18/08

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
20/04/2018

Title of the Project
A global randomized multicenter Phase 3 trial to compare the efficacy and safety of JCAR017 to standard of care in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (TRANSFORM).

Proposed period of release:
01/09/2019 to 30/11/2021

Name of the Institute(s) or Company(ies)
Celgene Corporation, 86 Morris Avenue, Summit, New Jersey 07901;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Denmark; Spain; France; United Kingdom; Italy; Netherlands; Sweden;

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):


GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
JCAR017 is a second generation CAR T cell construct comprised of autologous CD4+ and CD8+ T cells expressing a CD19-specific CAR consisting of an scFv binding domain derived from the FMC63 murine CD19-specific mAb fused to the 4-1BB and CD3ΞΆ chain signalling domains.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known